drugset / Trial / NCT05831774

IO Vancomycin in TSA

NCT05831774

Phase 4 Active not recruiting 33 enrolled The Methodist Hospital Research Institute
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.

Timeline

Start
2023-06-01
Primary completion
2024-07-15
Completion
2026-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 15 mg/kg Intravenous
Subject Vancomycin Other / unclassified 500 mg Intravenous

Indications